Clinical trials of an experimental cancer drug have been suspended after serious questions have been raised about the accuracy of some of the scientific data behind it.

The ABC has learnt that the University of New South Wales (UNSW) is investigating a number of allegations concerning the science and data underpinning the DZ13 compound.

DZ13 was developed by an Australian team of researchers led by Professor Levon Khachigian and heralded as a super drug in the fight against skin cancer.

Two investigations conducted at the UNSW into allegations against Professor Khachigian and his team found that there was no evidence of research misconduct.

But the current investigation was prompted by further concerns raised separately by an eminent Australian scientist and one of the former researchers on DZ13.

Both are concerned that images in a paper on DZ13, published in the Journal of Biological Chemistry in 2010, may not be genuine.

In a statement to the ABC, the UNSW said:

Patient safety is the university's top priority. The decision was made to err on the side of caution until concerns regarding some of the science underpinning DZ13 have been resolved. It should be stressed that these concerns do not relate to either the conduct of the trial or to the safety of the DZ13 compound.

Nine patients from New South Wales suffering from Australia's most common skin cancer, basal-cell carcinoma, were injected with DZ13.

The Lancet study found that there were no adverse or long-term side effects in any of the patients.

While the trial was only concerned with safety and tolerability, researchers reported that the target protein, c-jun was reduced in all nine patients and for five patients the depth of the tumour shrunk.

A second clinical trial on 38 patients with malignant melanoma was in the recruitment phase when it was suspended by the university.

UNSW's Dean of Medicine, Professor Peter Smith, said that the suspension of the trial was not done explicitly on the basis of the allegations but involved a number of factors that were being looked at by the university.

"When any concerns are raised about any research which is done at this university, this is taken very, very seriously and the concerns you are referring to have been brought to the attention of senior management and are being investigated under our Code of Research practice," he said.

Scientist asked university to investigate study

Professor David Vaux is an internationally acclaimed cell scientist at Melbourne's Walter and Eliza Hall Institute and lectures worldwide on research ethics.

"I think that anybody who has concerns of scientific misconduct, there's an ethical responsibility for them to raise those concerns with either the designated person to receive allegations of misconduct or with the journal editors or with the authors of the paper," he said.

In late 2009, he came across images in three papers from Professor Khachigian's lab relating to genetic research in the Journal of Biological Chemistry that he was concerned were inappropriately duplicated.

He wrote twice to the journal about his concerns that the images were not genuine.

In July 2010, the three papers were retracted by the authors, who said that the presentation of the images was a genuine error.

In February this year, Professor Vaux came across another paper in the Journal of Biological Chemistry that he said raised similar concerns of image duplication. This paper was focusing on DZ13.

Professor Vaux says this time there was more urgency, as the paper gave support to DZ13, which was about to be administered to patients in clinical trials.

He wrote to the vice-president and deputy vice-chancellor (research) at the University of New South Wales, Professor Les Field, asking for him to carry out an investigation.

I wish to alert you to concerns I have over a possible case of research misconduct at the UNSW.

In the paper attached I have annotated the images that I am concerned about...

They appear to contain duplications and/or alterations of images in such a way that the same data is used to represent two different conditions.

Professor Vaux also contacted the National Health and Medical Research Council in June.

I believe it would be important to act quickly, as patients may currently be receiving the agent described in the publication, DZ13, as part of a clinical trial.

If the results in this paper are not genuine, the Human Research Ethics Committee that approved the trial might have been misled, and the patients receiving the drug might not have been able to give properly informed consent.

Professor Khachigian is unable to comment on Professor Vaux's concerns because investigations are ongoing, but says that there has been no deliberate misrepresentation of data.

Researcher raises fresh allegations

Dr Ying Morgan, one of the scientists who worked on the original research, alleges that some of the experiments on DZ13 were not carried out correctly and that data had been misrepresented.

In early 2010, UNSW held a preliminary investigation into her concerns and two months later the allegations were rejected.

"It was found that there was no prima facie case of research misconduct and it was dismissed," Professor Smith said.

When Dr Morgan raised further concerns in 2010, a second investigation was launched by the university, this time with a panel including scientists from outside the UNSW. Dr Morgan was interviewed twice.

She says that one of her main concerns was that, at the time, DZ13 was being used as part of a human clinical trial.

The panel found that there was no research misconduct on the part of the scientists and that there was nothing to question the integrity of the science underpinning the trial.

The university considered the matter closed and the report was marked strictly confidential.

In a statement to the ABC, Professor Khachigian said "the research was not flawed. The independent inquiry panel found no case of research misconduct, nor any evidence of falsification, fabrication or misrepresentation of data."

But Dr Morgan has now raised what she believes to be other serious irregularities.

Like Professor Vaux, she alleges that crucial images in a paper published in the Journal of Biological Chemistry in 2010 were misrepresented.

Cancer patients placing trust in clinical trials

Former cancer patient John Stubbs believes passionately in the importance of clinical trials.

When he was diagnosed with leukaemia he took part in a trial of a drug which he says probably saved his life.

He says the majority of cancer patients would see clinical trials as a silver bullet, which is why it is so important for patients to be aware of all of the information surrounding a clinical trial.

"For many they would hope it's a cure, prolonging their life but also improving their quality of life," he says.

"You put your trust in the hands of the clinicians...it does put a real question over clinical trials."

Professor Smith says that the patients who have already undergone the clinical trials were not placed at risk.

"We did not have any information that cast any doubt at that point on the capacity to proceed with the (phase 1) trial," he said.

"There is always a balance in starting a clinical trial, when there is a discovery.

"There is the balance in determining whether we want to make that discovery available to treat patients and then there is always a risk.

"We felt the potential for DZ13 to help patients outweighed the risk and as I said, it was a phase 1 study starting at low dose, escalating the dose to see how well it was tolerated."

Scientist calls for authority to probe ethics

Professor Vaux believes that changes need to be made to the current system to improve transparency and accountability.

He would like to see an independent authority scientists can go to if they suspect research misconduct.

"It would be great if Australia had an office for research and integrity and an ombudsman for integrity, so any scientist who had any sort of concern or anybody reading a paper in any country in the world who saw something that they had concerns about, that they knew exactly where to go to and they could have some place that could in an independent way to find out what's really going on," he said.